1. Field of the Invention
The present invention relates to tissue sampling. More specifically, it relates to an apparatus and method for removing a sample of breast tissue for histo pathological examination. Even more specifically, it relates to an apparatus and method wherein a guiding spool is aligned over compressed breast tissue of a suspicious nature, the alignment is verified by the positioning of markings on the spool with those of the mammography apparatus, with the taking of an X-ray through the central aperture of the radiopaque spool to determine that the micro-calcification or lesion is located beneath, and with the advancement of a tube-like punch through the breast to remove the suspicious tissue for examination.
More generally, the invention relates to any type of alignment and sampling device wherein energy, which could be of various frequencies, is used to locate an anomalous area not immediately accessible, and where a bore or punch guide having an aperture therein that is transparent to the specified frequency is aligned over the anomalous area to confirm the accurate alignment and direct the punch to remove the area in question.
2. Description of the Prior Art
One of the most common forms of cancer is that of the female breast. Women are urged to examine themselves regularly for suspicious lumps or areas within the breast, and it is also recommended that a regular schedule of mammographic examination be maintained, especially above a certain age. In the case of non-palpable lesions or microcalcifications that are uncovered through these mammographies, it is necessary to obtain a sample of the suspicious tissue for histo pathological examination. This is done by various methods including surgical biopsy procedures and aspiration of the sample through needles. Both these methods have their drawbacks, however, in that the surgical procedure can entail a large initial incision, leaving a scar that can cause apprehension to the patient, and in the needle aspiration, that the microcalcification or lesion is still present in the breast, and that subsequent mammographies will reveal it, causing confusion, and the possibility of an unneeded, redundant second procedure. The present invention seeks to address these problems by providing a method and apparatus that substantially entirely removes the area in question while leaving a minimal amount of scarring. It secondly overcomes a disadvantage in the surgical procedures that require a guide wire placement in the breast and the subsequent moving of the patient to an operating theater for the actual excision of the tissue where, firstly, the guide wire can be dislodged from the correct position while the patient is transported and, secondly, the cost involved of providing and staffing the two separate locations or rooms in the medical facility. The present invention allows the practitioner to perform the procedure in one location, with the invasiveness thereof being kept to a minimum. In a search at the U.S. Patent and Trademark Office, a number of patents were uncovered that are deemed relevant to the instant invention:
In U.S. Pat. No. 5,197,482 issued on Mar. 30, 1993 to William R. Rank et al. there is disclosed a helical tipped lesion localization needle device and method. This constitutes a helically wound coil attached at both ends of a shaft, and is designed to be inserted into the body through a cannula. The helical construction allows the device to be rotated to advance the marker into the lesion for subsequent surgical procedures. In contrast to the present invention, the guide spool fastened to the outer portion of the patient is absent, as is the tubular hollow cutting punch of the present invention.
Next is U.S. Pat. No. 5,209,232 issued on May 11, 1993 to Simha Levene. This discloses a system of biopsy needle positioning wherein the position of the needle holder as it progresses into the patient's breast is monitored by a CPU such that images are provided to constantly update the progress of the biopsy needle towards the lesion. This is clearly different from the present invention in that no cutting punch is taught, the Levene patent being a positioning system for a needle prior to a surgical excision procedure.
In U.S. Pat. No. 5,056,523 issued on Oct. 15, 1991 to John E. Hotchkiss et al. there is disclosed a breast lesion localizer. This involves a first and second radiolucent platform that are in a movable, parallel, and spaced apart relationship to one another. The uppermost of these platforms contains an insert with a plurality of probe passages. Radiopaque scales are provided coplanar to the probe positioning guide to allow the operator to judge the depth of the lesion relative to the platforms and, thus, the probe guides. The probe can thus be inserted proximate the suspicious tissue and the tissue aspirated. Unlike the instant invention, there is no teaching of the guide spool, the aperture therein, nor of the tubular cutting member for the excision of the tissue.
U.S. Pat. No. 5,213,100 issued on May 25, 1993 to Herbert Summ discloses a mammography apparatus with a stereotactic biopsy unit. In this device, the holders for the biopsy needle extend parallel to the plane of exposure and have at their ends releasable closures that allow the patient to be moved away from the unit after the placement of the needles without disturbing the placement of the indicating needles. As in the patents discussed above, there is not seen the guide spool with its radiopaque aperture for alignment with the suspect tissue, nor is there seen the cutting punch of the present invention.
Lastly, U.S. Pat. No. 5,078,142 issued on Jan. 7, 1992 to Bernard W. Siczek et al. discloses a mammographic needle biopsy system. In this invention, the patient lies on a table which includes a breast aperture through which the breast pendulantly protrudes. A compression paddle presses the breast against an X-ray film holder and a needle holder that is adjustable through azimuth, elevation, and insertion depth is controlled through a computer to place the aspirating needle at the suspect area. Unlike the instant invention, there is no complete excision of the suspect area, nor is the guide spool required for the present invention taught.
None of the above inventions and patents, taken either singly or in combination, is seen to describe the instant invention as claimed.